DMC MEDICAL LIMITED

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Syringe, Antistick (MEG) (6) Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (3) Catheter, Irrigation (GBX) (1)

Premarket Exempt

Clear

SVDS200 SAPHENOUS VEIN DISTENTION SYSTEM - 200mmHg - 05391530750035 Catalog Number : FD-1003

Device Description : Saphenous Vein Distention System - 200mmHg - Sterile

Device Class : 2

Duns Number: 989772017

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHg - 05391530750066 Catalog Number : FD-1004

Device Description : Saphenous Vein Distention System - 300mmHg - Sterile

Device Class : 2

Duns Number: 989772017

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Vein Irrigation Cannula DMC VIC Sterile - 05391530750097 Catalog Number : FD-1006

Device Description : Vein Irrigation Cannula Sterile

Device Class : 1

Duns Number: 989772017

Premarket Exempt : No

Product Code : GBX

Prescription Use : No

Device Count : 1

Cardiac Insulation Pad Adult Sterile - 05391530750127 Catalog Number : FD-1001

Device Description : Cardiac Insulation Pad Adult Sterile

Device Class : 2

Duns Number: 989772017

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

1ml Insulin Suresafe Syringe - 05391530750158 Catalog Number : FD-SSFX01L-29

Device Description : 1ml Insulin Automatic Retractable Syringe - 29G x 1/2" - Sterile

Device Class : 2

Duns Number: 989772017

Premarket Exempt : No

Product Code : MEG

Prescription Use : No

Device Count : 1

1ml Tuberculin Suresafe Syringe - 05391530750189 Catalog Number : FD-SSFX01L-27

Device Description : 1ml Tuberculin Automatic Retractable Safety Syringe - 27G x 1/2" - Sterile

Device Class : 2

Duns Number: 989772017

Premarket Exempt : No

Product Code : MEG

Prescription Use : No

Device Count : 1

1ml Tuberculin Suresafe Syringe - 05391530750219 Catalog Number : FD-SSFX01T-25

Device Description : 1ml Tuberculin Automatic Retraction Safety Syringe - 25G x 5/8" - Sterile

Device Class : 2

Duns Number: 989772017

Premarket Exempt : No

Product Code : MEG

Prescription Use : No

Device Count : 1

1ml Tuberculin Suresafe Syringe - 05391530750240 Catalog Number : FD-SSFX01T-25-01

Device Description : 1ml Tuberculin Suresafe Automatic Retractable Safety Syringe - 25G x 1" - Sterile

Device Class : 2

Duns Number: 989772017

Premarket Exempt : No

Product Code : MEG

Prescription Use : No

Device Count : 1

Suresafe 1ml Syringe - 05391530750271 Catalog Number : FD-SSFX01-25

Device Description : Suresafe 1ml syringe - 25G x 5/8" Automatic retractable syringe - Sterile

Device Class : 2

Duns Number: 989772017

Premarket Exempt : No

Product Code : MEG

Prescription Use : No

Device Count : 1

Suresafe 1ml Syringe - 05391530750301 Catalog Number : FD-SSFX01-25-01

Device Description : Suresafe 1ml Syringe - Automatic Retraction - 25G x 1" Sterile Syringe

Device Class : 2

Duns Number: 989772017

Premarket Exempt : No

Product Code : MEG

Prescription Use : No

Device Count : 1

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